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Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients

Primary Purpose

Copd, Asthma, Respiratory Effort

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Investigational Device: Contactless heart rate and respiratory rate monitor

Heart Rate (EKG) Monitor

Respiratory rate Monitor

Pulse Oximetry

About this trial

This is an interventional device feasibility trial for Copd

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient seen at the Stanford University Hospital Chest Clinic
Patient age 18 or older
Patient able to consent
Patient with one of the following two medical conditions: Chronic Obstructive Pulmonary - Disease or Asthma
Participant (or accompanying family / caretaker) able to speak English

Exclusion Criteria:

Patient does not meet inclusion criteria (under age 18, unable to consent, etc.)
Patient is hospitalized
Patient is having an acute exacerbation of their respiratory condition
Patient is having an acute exacerbation of a comorbid condition
Patient has comorbid cardiac disease, including one of the conditions listed below:
Arrhythmias (including atrial fibrillation, NSVT, etc.)
Congestive Heart Failure
Unstable angina
Myocardial infarction within the last 3 months prior to enrollment
Uncorrected congenital heart disease
Uncorrected severe valvular disease
Pulmonary Hypertension (moderate or higher grade)
Patient has one of the following conditions:
Moderate pleural effusion
Large pleural effusion
Advanced stage lung cancer (Stage III or Stage IV disease)
Active infectious process, including viral process or pneumonia
Interstitial lung disease
Pleural disease, including pleural malignancies, trapped lung, etc
Active Cheyne-Stokes respiration
Patient has baseline increased work of breathing not due to their underlying respiratory disease (ie. COPD or asthma)
Ongoing substance abuse (not including cigarette use)

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Device Arm

Arm Description

Once consented for the study, participants will undergo testing with the investigational device for a one hour period. Testing will entail the participant wearing an EKG monitor, a respiratory rate monitor, a pulse oximeter, and being positioned next to the investigational device. The investigational device is contactless and captures chest movement of participants which allows it to estimate real time heart rate and respiratory rate. Additional data collected with the EKG monitor, respiratory rate monitor, and the pulse oximeter will be used to validate the vital sign data collected by the investigational device. After data collection is complete, participant involvement will then be over. Participants will have the option to return on a later date for additional testing (up to a maximum of three sessions total), within the six month window of the study. Participants will continue their standard of care therapies for their respiratory condition.

Outcomes

Primary Outcome Measures

Heart Rate

Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.

Respiratory rate

Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.

Secondary Outcome Measures

Full Information

NCT ID

NCT04003415

First Posted

June 26, 2019

Last Updated

September 22, 2021

Sponsor

Stanford University

Collaborators

Work of Breathing Study Group

1. Study Identification

Unique Protocol Identification Number

NCT04003415

Brief Title

Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients

Official Title

Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

September 20, 2021 (Actual)

Study Completion Date

September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Work of Breathing Study Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study will test the accuracy of an investigational, non-invasive device for measuring heart rate and respiratory rate. The device emits radiowaves that allows it to pick up subtle changes in a person's chest wall, which allows it to calculate the heart rate and respiratory rate. We propose to study whether the device's measurements are accurate and reproducible in patients with chronic obstructive pulmonary disease (COPD) or asthma. The device undergoing study has been evaluated in healthy volunteers, but its accuracy in vital sign monitoring in patients with respiratory conditions has not yet been established. This study will serve as the foundation for additional work to assess the device's accuracy in measuring a patient's overall "work of breathing" or respiratory effort. Future work will examine the device's accuracy in measuring work of breathing in patients having an exacerbation of their underlying respiratory condition. The primary aim of this study will be to assess the validity of heart rate and respiratory rate measurements in patients with either COPD or asthma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Copd, Asthma, Respiratory Effort, Contactless Vital Sign Monitoring

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All participants enrolled in the study will be in the intervention arm. Intervention consists of device feasibility and validation of heart rate and respiratory rate data collected.

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Investigational Device Arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Investigational Device: Contactless heart rate and respiratory rate monitor

Other Intervention Name(s)

Investigational Device

Intervention Description

Participant will be seated next to the investigational device. The device is contactless, and will measure the patient's heart rate and respiratory rate through use of radio-waves.

Intervention Type

Diagnostic Test

Intervention Name(s)

Heart Rate (EKG) Monitor

Intervention Description

Participant will undergo 3-lead EKG testing to measure heart rate during testing.

Intervention Type

Diagnostic Test

Intervention Name(s)

Respiratory rate Monitor

Intervention Description

Participant will have an elastic band around their chest for monitoring respiratory rate during testing.

Intervention Type

Diagnostic Test

Intervention Name(s)

Pulse Oximetry

Intervention Description

Participants will wear a finger pulse oximeter during the testing for monitoring of heart rate, respiratory rate, and pulse oximetry.

Primary Outcome Measure Information:

Title

Heart Rate

Description

Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.

Time Frame

30 - 60 minutes

Title

Respiratory rate

Description

Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.

Time Frame

30 - 60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient seen at the Stanford University Hospital Chest Clinic Patient age 18 or older Patient able to consent Patient with one of the following two medical conditions: Chronic Obstructive Pulmonary - Disease or Asthma Participant (or accompanying family / caretaker) able to speak English Exclusion Criteria: Patient does not meet inclusion criteria (under age 18, unable to consent, etc.) Patient is hospitalized Patient is having an acute exacerbation of their respiratory condition Patient is having an acute exacerbation of a comorbid condition Patient has comorbid cardiac disease, including one of the conditions listed below: Arrhythmias (including atrial fibrillation, NSVT, etc.) Congestive Heart Failure Unstable angina Myocardial infarction within the last 3 months prior to enrollment Uncorrected congenital heart disease Uncorrected severe valvular disease Pulmonary Hypertension (moderate or higher grade) Patient has one of the following conditions: Moderate pleural effusion Large pleural effusion Advanced stage lung cancer (Stage III or Stage IV disease) Active infectious process, including viral process or pneumonia Interstitial lung disease Pleural disease, including pleural malignancies, trapped lung, etc Active Cheyne-Stokes respiration Patient has baseline increased work of breathing not due to their underlying respiratory disease (ie. COPD or asthma) Ongoing substance abuse (not including cigarette use)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Jonas

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Full Access: Access to Data, Access to patient PHI, Access to RedCap Document linking patients to their study numbers. Limited Access: Access to de-identified participant data for analysis Study PI and Study Faculty Sponsor: Full Access Research Team and Industry Sponsors: Limited Access Upon enrollment each participant will be assigned a unique study number. Any study data collected will be linked to the patient solely through the study number. The document that contains the patient information and their study numbers will by kept on Stanford RedCap and will only be accessible by the study PI and the faculty sponsor. De-identified data of vital sign measurements will be shared between the Stanford research team and industry collaborators. Data will be downloaded to an encrypted USB key and hand-delivered between members of the research team. For smaller files, de-identified patient data will be mailed securely between the research team members.

IPD Sharing Time Frame

Data collection will take place over the course of a 6 month period. De-identified patient data will be kept for a period of 5 years.

IPD Sharing Access Criteria

Access to patient PHI will be limited to the study PI and the faculty sponsor. Access to de-identified patient data will be allowed for research and industry collaborators for analysis.

Citations:

Citation

W. Li, B. Tan and R. J. Piechocki,

Results Reference

background

Citation

Levitas, I. Naidionova and J. Matuzas,

Results Reference

background

Links:

URL

http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=7511389&isnumber=7510595

Description

Reference 1

URL

http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=6869188&isnumber=6869176

Description

Reference 2

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Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients

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